Changes to Lysine supply in the EU: Be ready for the transition

20-May-2020 - Last updated on 20-May-2020 at 09:49 GMT

New EU regulation re-authorizing the various forms of the essential amino acid, Lysine, that can be placed on the EU market brings plenty of changes, says Didier Jans, managing director, SERRPA, a consultancy specialized in regulatory and public affairs.

The responsibility to comply with the rules lays of course on the supplier, but according to the EU General Food Law, the user is responsible as well. “No-one can hide behind the supply chain,” said Jans.

A critical element of the new authorization package is that it is now specified from which microorganism strain each form of lysine can be manufactured, said the consultant.

The authorized strains are proprietary - in total, six global producers share the various authorizations granted, said Jans. Those producers are now harvesting the fruit of their applications, which they tabled and supported throughout the EFSA assessment over the last 10 years, he noted.

Smooth transition

The new regulation includes provisions intended to facilitate a smooth transition, for both Lysine suppliers and for the users, he said. The new authorizations have been in place since December 2019, but Lysine (preparations or premixtures) produced according to the previous regulation can still be placed on the EU market until June 18, 2020, he added.

According to the EU law, this implies that the product must physically exist at the time of the transaction, said Jans.

As far as compound feed is concerned, companies can integrate the previous Lysine forms if the feed is manufactured and labelled before December 18, 2020 and December 2021 for non-food producing animals, he said.

The case of Lysine sulphate is a bit more restrictive, said Jans.

“In this case the former authorization was already restricted to production through fermentation with Corynebacterium glutamicum. L-lysine sulphate produced with a microorganism species other than Corynebacterium glutamicum (e.g. Escherichia coli) cannot benefit from the transition regime, and, in fact, is illegal, except if produced with Escherichia coli strain CGMCC3705 that was duly authorized through Regulation (EU) 2017/439).”

Summary table of Lysine authorizations under Regulation 1831/2003 and comparison to previous ones under Directive 88/485/EEC

Old authorization	New authorization
Directive 88/485/EEC	Regulation (EU) 1831/2003
	(EU) Regulation 2017/1145
3.2.1 L-Lysine, technically pure (L-Lysine min 98%)	Withdrawn authorization
	(EU) Regulation 2019/1964
3.2.2 Concentrated liquid L-Lysine (base) (L-Lysine min 60%)	3c320 L-lysine base, liquid (L-Lysine min 50%)	Produced by fermentation with Escherichia coli FERM BP-10941 FERM BP-11355
		Produced by fermentation with Corynebacterium glutamicum KCCM 11117P NRRL B-50547 NRRL B-50775 KCCM 10227
	(EU) Regulation 2019/1964
3.2.3 L-Lysine-monohydrochloride, technically pure (L-Lysine min 78%)	3c322 L-lysine monohydrochloride, technically pure (L-Lysine min 78%) (Max moisture 1.5%)	Produced by fermentation with Escherichia coli FERM BP-10941 FERM BP-11355 CGMCC 3705 CGMCC 7.57
		Produced by fermentation with Corynebacterium glutamicum NRRL B-50547 NRRL B-50775 KCCM 11117P KCCM 10227
	(EU) Regulation 2019/1964
3.2.4 Concentrated liquid L-Lysine-monohydrochloride (L-Lysine min 22.4%)	3c321 L-lysine monohydrochloride, liquid (L-Lysine min 22%) (L-Lysine in dry matter min 58%) (max moisture 66%)	Produced by fermentation with Escherichia coli FERM BP-10941 FERM BP-11355
	Regulation (EU) 2019/1964
3.2.5 L-Lysine-sulphate Produced by fermentation with Corynebacterium glutamicum (L-lysine min 40%)	3c324 L-lysine sulphate (L-Lysine min 52%) (Max sulphate 24%)	Produced by fermentation with Corynebacterium glutamicum KCCM 10227 DSM 24990
	Regulation (EU) 2017/439
	3c323 L-lysine sulphate (L-Lysine min 55%) (Max sulphate 22%) (Max moisture 4%)	Escherichia coli CGMCC 3705

Traceability checks

Compared to the previous situation, the conditions of use and labelling requirements have evolved, he said.

“One of the important compliance aspects then relates to the microorganism strains. This traceability information must be secured and communicated through the value chain. Although it is not a formal labelling requirement, some producers have already decided to include the strain identification (deposit code) into their product label as a part of the product identity.

“The June 18 deadline is approaching rapidly; it is advisable for any concerned supplier/user to take action to secure future supplies.”

Additional traceability checks might be secured as suggested in the toolbox below, said the consultant.

Toolbox: How can suppliers/users secure compliance with the production strain requirement?

1. Check product documentation from the supplier.

The product documentation should clearly confirm which was the microorganism strain used for manufacturing the product and this should fit to the name and identification number that is specified in the official authorization. This should be applicable to each batch.

2. Make sure that the supplier has ownership of this strain.

All the authorized strains are proprietary. It is easy for a producer to document that it has ownership on a given strain by providing a copy of the deposit certificate in an internationally recognized culture collection. This certificate should include the strain name, identification number and the references of the company. If you are interacting with an intermediary, this later one should be able to provide this documentation from the producer.

3. Get insights into license agreements when necessary.

It may happen that a producer is manufacturing with an authorized strain, under license from the owner of the strain. This should be documented through convincing document.

4. Check status of the supplier under FAMI-QS.

Under version 6.0 of the scheme, there is a public access to the list of additives that are under the scope of activities of each certified company. This include the name of the additives. Under the certification rules (certifications instruction CI-19-04), the auditor must check which micro-organism strain is used for the production.

5. Implement proportionate analytical control.

The documentation mentioned above is giving a fair level of traceability assurance. There might however be cases where additional guarantee that a given batch was produced with the specified microorganism can be sought. This can be further checked through analysis. This control however requires information (e.g. about some genetic characteristics of the strain) that are not public and might even be IP sensitive. It also requires experience in the relevant analytical methods which may have to be adapted and validated for different feed matrices. This should be settled bilaterally between each supplier and its users in a trustful relationship.